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May 06, 2013

Dawson v. Dawson (Fed. Cir. 2013)

On
March 25, the Federal Circuit in Dawson
v. Dawson affirmed a determination by the Board of Patent Appeals and
Interferences that the University of California, San Francisco (UCSF) failed to
establish sole conception by Dr. Chandler Dawson of the claimed inventions in
two patents assigned to InSite Vision Inc.
The case involved an interference between two patents, U.S. Patent Nos.
6,239,113 and 6,569,443, which name Dr. Dawson and Dr. Lyle Bowman as inventors
and which are assigned to InSite, and an application which names Dr. Dawson as
the sole inventor and which is assigned to UCSF. The patents and application ay issue are
directed to a method for topically treating and preventing infections of the
eye.

In
1997, at a meeting of the World Health Organization Alliance for the
Elimination of Trachoma, Dr. Dawson, who was employed by UCSF, gave a
presentation on the topical use of an antibiotic called azithromycin (at right) to control
trachoma (a bacterial infection of the eye).
A report of the meeting ("WHO Report") was subsequently
released, which included a discussion of Dr. Dawson's presentation. A second document ("WHO document"),
which may have been an outline of Dr. Dawson's presentation, provided a similar
discussion of the presentation.

Shortly
after the meeting, Dr. Dawson asked Dr. Kenneth Chern to enlist the assistance
of Dr. Bowman, an employee at InSite (a company involved in the research and
development of ophthalmic products), in creating a suitable ophthalmic medication
with azithromycin that could be applied topically to the eye. Dr. Chern sent 100 mg of azithromycin to Dr.
Bowman for formulating as a topical preparation. Three weeks later, after not hearing back
from Dr. Bowman, Dr. Chern sent azithromycin to Dr. Charles Leiter, a
pharmacist associated with the same foundation as Dr. Chern, to formulate as an
ointment or suspension. Dr. Leiter
prepared an ointment using a mineral oil and petrolatum carrier and containing 0.5%
azithromycin by weight. Upon receipt,
Dr. Chern applied some of the ointment to his own eye to determine whether it
could be well-tolerated, and informed Dr. Dawson of the results of his experiment. Dr. Dawson subsequently left UCSF to work at
InSite, and after joining InSite, was named with Dr. Bowman on a patent
application that led to the issuance of the '113 and '443 patents.

Almost
four years after the '443 patent issued, UCSF filed a patent application naming
Dr. Dawson as an inventor, and copying the specification and claims from both
the '113 and '443 patents in order to provoke an interference. The BPAI declared two interferences between
the InSite patents and UCSF's application, naming UCSF as the junior party (and
therefore UCSFD bore the burden of proving, by a preponderance of the evidence, that
Dr. Dawson alone had conceived of the inventions recited in the counts prior to
InSite's March 31, 1999 filing date).
The count in Interference 105,719, which tracks claim 3 of the '113
patent, recites:

A process for treating an eye, which
comprises: topically
applying an aqueous polymeric suspension of an azalide antibiotic, wherein said
suspension comprises water, 0.01%
to 1.0% of an azalide antibiotic, and 0.1
to 10% of a polymeric suspending agent which is a water-swellable
water-insoluble cross-linked carboxy-vinyl
polymer which comprises at least 90% acrylic acid monomers and 0.1% to 5%
crosslinking agent.

The
count in Interference 105,729, which tracks claim 1 of the '443 patent, recites:

A process for treating an eye, comprising: topically
applying an azalide antibiotic to an eye in an amount effective to treat
infection in a tissue of the eye, wherein said topically applying comprises
supplying a depot of a composition containing said azalide antibiotic on the
eye.

On
the issue of conception, the Board determined that UCSF had failed to prove
sole conception by Dr. Dawson, finding that that Dr. Dawson did not fully
appreciate how his idea was to be implemented in actual practice, and that it
was only after Dr. Bowman became involved that "'something' significant
happened," leading to the March 1999 filing of Dr. Dawson's and Dr.
Bowman's application. UCSF appealed the
Board's decision, contending the Board erred in finding that Dr. Dawson did not
conceive of the claimed inventions by himself prior to his collaboration with
Dr. Bowman.

In
a majority opinion written by Judge Bryson and joined by Judge Wallach, the
Federal Circuit began by noting "that the nature of the evidence presented
in this case is unusual," as the Court was "asked to decide whether
and when an invention formed definitely, permanently, and particularly in the
mind of the alleged inventor, but to do so without any testimony from the
supposed inventor himself." Instead
of providing testimony from Dr. Dawson, UCSF contended that the WHO Report and
the WHO document prove Dr. Dawson's conception, and that Dr. Leiter's
preparation of an ointment for Dr. Chern provided further corroboration. The Court, however, disagreed with UCSF's
contention, stating that "[a]t best, . . . the WHO Report and WHO document
announce a general idea, acknowledge many of the difficulties associated with making
that idea operative, and offer some thoughts on how one might proceed
(including by listing a few potential delivery vehicles)." The Court explained (citations omitted) that:

The WHO document is entitled "Potential
Use of Topical Azithromycin in Trachoma Control Programmes," and the WHO
Report describes Dr. Dawson's presentation as a "preliminary report on the
possibility of developing a topical application of azithromycin," while
"recommend[ing] that [Dr.] Dawson continue to work with [others] to
develop a topical application and report back at the next meeting." A "preliminary" statement about a
"possibility" or "potential use," alongside a recommendation
for continued work and a "report back" in the future, falls short of
a "'definite and permanent idea of the complete and operative invention,
as it is hereafter to be applied in practice.'"

Stating
that "[t]he inadequacy of UCSF's showing is equally clear in the context
of the specific interference counts," the Court noted that UCSF's evidence
failed to establish conception of the specific concentrations in the '719
count, and further, that UCSF failed to establish that Dr. Dawson on his own
determined "an amount effective to treat infection in a tissue of the eye"
as recited in the '729 count.

The
Court also noted that the ointment prepared by Dr. Leiter for Dr. Chern did not
establish that Dr. Dawson alone conceived of the subject matter of the counts
because "[t]here is no evidence that Dr. Dawson instructed Dr. Chern to
contact Dr. Leiter or otherwise had any direct connection to the preparation of
the ointment."

On
appeal, UCSF argued that the Board's decision on conception was infected by
several errors in claim construction and admission of evidence. In response to UCSF's argument that the
preamble of the '719 count should not have been read as limiting, and that
treatment can be proactive and can thus occur absent an active infection, the
Court countered that "[t]he proper meaning and scope of the preamble . . .
is irrelevant to our conclusion that UCSF failed to prove sole conception by
Dr. Dawson." In response to UCSF's
argument that the Board erred in considering statements from the specifications
of the '113 and '443 patents on the ground that those statements were inadmissible
hearsay, the Court noted that "UCSF adopted the words in the '113 and '443
patents as its own when it 'copied' those words into the patent application
that provoked these interferences."
In response to USCF's argument that the Board erred by failing to
consider statements made by InSite in an opposition to a European patent
application concerning the topical use of azithromycin (InSite had stated in opposition proceedings that the
WHO document "disclos[es] . . . why topical azithromycin preparations for
eye treatment are highly desirable" and provides "a concrete
disclosure [of] how such preparations can be obtained" and "suggestions
[on] how [they] could be made"), the Court determined that the Board did
not abuse its discretion by following its general rule against giving
controlling weight to documents from foreign patent proceedings. The Court also pointed out that the Board had
properly noted that the instant case involved the issues of conception and
reduction to practice and not lack of novelty or inventive step, the latter of which
were at issue in the opposition.

Writing
in dissent, Judge Reyna stated that:

The record before us demonstrates that Dr. Dawson possessed a definite and
permanent idea of his complete and operative invention when, in the summer of
1997, he delivered a related presentation at a conference of the World Health
Organization ("WHO"). At that
time, Dr. Dawson was employed by UCSF, not InSite. Consequently, I find that Dr. Dawson, through
UCSF, satisfied his burden of demonstrating prior conception.

The
dissent continued by asserting that the WHO Report and WHO document teach each
of the limitations of the '729 count, and establish that he had possession of
each recited feature. In particular, the
WHO references disclose (1) treating an eye, (2) topically applying an azalide
antibiotic (i.e., azithromycin) (3)
an effective dose ("Dr. Dawson suggested that his azithromycin formulation
would use the same dosage known for erythromycin," and the dose "0.5%
by weight[] is used throughout Dr. Dawson's patent as a preferred formulation),
(4) supplying a depot containing the azalide antibiotic ("[b]oth references
contain the same table listing five alternative delivery depots, one of which
is [InSite's] Durasite"). The dissent
concluded that "Dr. Dawson's WHO presentation and the accompanying report
disclose each element of at least the '729 count, and as such, the two WHO
references are sufficient to demonstrate Dr. Dawson's prior conception."

In the interference proceeding, the Board considered whether Dr. Chern's
experiment showed reduction to practice before the critical date. The Board held that Dr. Chern's experiment
could not be reduction to practice because Chern had not applied the ointment
to an actual infection. The Board based
its determination on its construction of "treating" an eye, which it
construed as "retarding or suppressing infection in a tissue of" an
eye. Because Dr. Chern had not applied
the ointment to treat an actual infection, the Board held that Dr. Chern did
not reduce Dr. Dawson's invention to practice.
The Board erred in two fundamental aspects. First, the term "treating an eye"
in the preamble of the count is not limiting.
Second, "treating an eye" does not require an actual infection.

The
dissent concluded by stating that:

The question is: because Dr. Dawson's WHO presentation demonstrated
conception and Dr. Chern's experiment demonstrated reduction to practice, what
is left to establish inventorship? The
majority opinion leaves open for interpretation whether commercialization is
required for full conception.

But conception does not require
commercialization, nor does commercialization establish initial invention. On the contrary, the record shows that Dr.
Dawson conceived his invention at UCSF. He
turned to Dr. Bowman at InSite only for assistance in commercializing his
invention.